Impact of participation in randomized trials on outcome following surgery for gastro-oesophageal reflux

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Abstract

Introduction
Patients are unwilling to participate in clinical trials if they perceive risks. To identify how trial participation impacts on outcome, outcomes were evaluated following surgery for gastro-oesophageal reflux in patients recruited to randomised trials vs. patients not in trials.
Patients and Methods
From 1994 to 2009, 417 patients entered 6 randomised trials evaluating surgery for reflux, and 980 underwent surgery outside the trials. The choice of procedure outside the trials was according to surgeon or patient preference. Clinical outcomes were determined 1 and 5 years after surgery using a standardised questionnaire, including analogue scales to assess heartburn and dysphagia, and overall satisfaction with the outcome. Subgroup analysis was undertaken for those aged < 75 yrs undergoing laparoscopic Nissen fundoplication.
Results
The trial group contained a higher proportion of men, were younger, more likely to have Barrett’s oesophagus, and have undergone a Nissen fundoplication. Reoperations within 5 years were more common in the trials group. At one year patients in the trials had slightly lower heartburn scores, and less abdominal bloating, but otherwise similar outcomes to those not in the trials. At five years there were no differences except a slightly higher dysphagia score for liquids in the trials group. For the subgroup analysis demographic data were similar for both groups, and at one year there were no differences. At 5 yrs patients enrolled in the trials had higher scores for dysphagia for liquids. The magnitude of all statistically significant differences were unlikely to be clinically significant.
Conclusion
Participation in a randomised trial assessing surgery for reflux does not impact outcomes.